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SAPIEN 3 Ultra System PMCF | Clinical Trials | Clareo Health

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Active Not RecruitingNCT04555967

SAPIEN 3 Ultra System PMCF

A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.

Lead sponsor: Edwards Lifesciences•11 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Edwards Lifesciences

To monitor and review device performance and outcomes of the SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.

Age

All ages

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•1. Subject meets the criteria per the Indication and Contraindications according to the current IFUs.
•* Indication for Use: The Edwards SAPIEN 3 Ultra THV, the Edwards SAPIEN 3 THV, and the associated delivery systems are indicated for use in patients with severe, symptomatic, calcific aortic valve stenosis who are judged by a Heart Team, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% at 30 days, based on the STS risk score and other clinical comorbidities unmeasured by the STS risk calculator).
•* Contraindications: Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis; Inability to tolerate anticoagulation/antiplatelet therapy.
•2. Subject has provided written informed consent to comply with all study procedures and follow-up visits

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 15, 2026Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

Phase—

Enrollment200

Start dateJun 2020

Last updatedApr 15, 2026

Condition

Aortic Valve Stenosis

Locations shown

Medizinische Universitaet Wien

Vienna

St. Paul's Hospital Vancouver

Vancouver, British Columbia

Aarhus University Hospital, Skejby

Aarhus

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 15, 2026Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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